Efficacy of Intrathecal Oxytocin in Human Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hyperalgesia
研究概览
简要总结
The purpose of this study is to determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.
详细描述
Purpose: There is a strong experimental basis to support the study of oxytocin by the spinal route for analgesia in humans. Oxytocin containing cells in the dorsal parvocellular division of the paraventricular nucleus (PVN) project to the spinal cord (1). Noxious stimulation activates these cells via the A1 noradrenergic relay in the pons (2) and produces analgesia by spinal release of oxytocin, since intrathecal injection of an oxytocin receptor antagonist worsens pain behaviors from peripheral inflammation (3). Direct electrical stimulation of the PVN reduces dorsal horn neuronal responses to noxious stimulation, and this is blocked by administration of sequestering antibody for oxytocin (4). Similarly, direct electrical stimulation of the PVN reduces behavioral sensitivity in a model of chronic neuropathic pain, and this effect is blocked by an oxytocin receptor antagonist (5). Intrathecal injection of oxytocin in normal rats reduces dorsal horn neuronal responses to noxious stimuli (6) as well as behavioral responses to noxious thermal (3), mechanical (3), and chemical (7) stimuli. Finally, intrathecal injection of oxytocin in rat models of chronic pain also reduces dorsal horn neuronal responses to sensory stimulation (6) as well as behavioral responses to thermal (5) and mechanical (7) stimuli.
Rationale: We anticipate that oxytocin will be effective after spinal injection in humans against chemical induced hypersensitivity states.
Objectives: Determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization is prepared by a statistician not otherwise involved in the study or data analysis and is maintained by the Wake Forest University School of Medicine research pharmacy. Study drug is dispensed by the research pharmacy labelled as "Study drug containing normal saline or oxytocin 15 mcg in normal saline or oxytocin 150 mcg in normal saline" to indicate the possible contents of the solution, thereby maintaining blind.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •weight < 240 pounds
- •American Society of Anesthesiology Category 1 or 2
排除标准
- •allergy to oxytocin or lidocaine
- •allergy to chilli peppers
- •Females: active gynecological disease such as uterine fibroids or ongoing bleeding
- •Pregnancy or currently breastfeeding
- •Females that have delivered a baby within 2 years of study
- •Taking prescription medications (exception: oral birth control medication)
研究组 & 干预措施
Oxytocin 15 mcg
Oxytocin 15 mcg injected spinally
干预措施: Oxytocin 15 mcg (Drug)
Oxytocin 150 mcg
Oxytocin 150 mcg injected spinally
干预措施: Oxytocin 150 mcg (Drug)
Placebo
Preservative free normal saline injected spinally
干预措施: Placebo (Drug)
结局指标
主要结局
Hyperalgesia
时间窗: 105 minutes after study drug injection
The area of hyperalgesia after the first skin heating following topical capsaicin.
次要结局
未报告次要终点